Pelvic Organ Prolapse
Conditions
Keywords
GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh, POP
Brief summary
The objective of this retrospective and prospective, single-arm, observational, multicenter, post-market study is to evaluate outcomes in women who underwent surgery for vaginal or uterine prolapse with a GYNEMESH PS Mesh.
Interventions
DEVICEIntervention
There is no intervention, beyond necessary clinical care, in this study. The surgical procedures that were performed in subjects within this study are identical to the surgical procedures the subjects would have received as part of SOC.
Sponsors
Ethicon, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study: 1. Female subjects who had laparotomic or laparoscopic abdominal sacrocolpopexy, including robotic-assisted, for apical vaginal or uterine prolapse 2. GYNEMESH PS Mesh was used as a bridging material according to the IFU. 3. Able and willing to participate in follow-up 4. Subject or authorized representative has signed the approved informed consent
Exclusion criteria
Subjects meeting any of the following criteria will be considered not eligible for enrollment in this study: 1. Subjects \< 21 years of age at the time of informed consent 2. Subjects who had transvaginal approach for surgery 3. Had undergone a uterus-sparing procedure (sacrohystero or sacrocervicopexy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment CHange | Post-surgery through study completion, approximately 7 yrs | Objective cure of vaginal or uterine prolapse approximately 7 years after surgery, defined as POP-Q stage ≤2 at point C as determined with physical exam. |
Secondary
| Measure | Time frame |
|---|---|
| Patient Global Impression of Improvement (PGI-I) or Patient Global Impression of Change (PGI-C) Questionnaire | Post-surgery through study completion, approximately 7yrs |
| Pelvic Floor Distress Inventory (PFDI-20) Questionnaire | Post-surgery through study completion, approximately 7yrs |
| Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) or Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) | Post-surgery through study completion, approximately 7yrs |
Countries
Germany, United States
Contacts
STUDY_DIRECTORMartin Weisberg, MD
Ethicon, Inc.
Outcome results
None listed